MAUDE Adverse Event Report: SWANN MORTON LTD. SWANN-MORTON NO.15 CARBON STERILE BLADE; SCAPEL BLADE

Model Number	NO.15 CARBON STERILE BLADE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Please see the description provided by the healthcare facility "#15 blade blade broke off while in use and extended surgical time with difficulty in retrieval of the piece broken off in patient wound.Physician stated he utilized minimal action in blade manipulation before the break.The patient had no post-op complications and is doing well".
Additional Manufacturer Narrative
Please see below the response sent to the customer."thank you for informing us of your customer complaint where a carbon sterile sm15 blade broke during surgery.With this blade breaking during a surgical procedure, it falls into the category of an adverse incident and therefore must be reported to the relevant competent authorities.Unfortunately, the blade in question or sample blades from the same shelf box or lot number are not available to be returned for our investigation.We have also received no information on the procedure that was being performed at the time of the breakage and no lot number information for the blade in question.Without having the blade in question returned or sample blades, we are unable to check the heat treatment hardness to determine whether the blade had been manufactured to the surgical blade standard bs 2982 of which we claim compliance.Without the lot number, we are unable to check our in-process records for any problems and our history to see if we have received any further customer complaints of this nature.We hope you will understand that it is difficult for us to comment further on how this blade came to break due to us receiving limited information and no sample blades to test.If the relevant information and sample blades were to become available and returned, we would be able to perform a thorough investigation and issue you with a further report detailing our findings.If we can be of any further assistance, please do not hesitate to contact us." this was also submitted to the fda under distributor mdr #1423395-2023-00077.

• Brand Name: SWANN-MORTON NO.15 CARBON STERILE BLADE
• Common Device Name: SCAPEL BLADE
• Manufacturer (Section D): SWANN MORTON LTD.; owlerton green; sheffield, , gb S6 2B J; UK S6 2BJ
• Manufacturer (Section G): SWANN MORTON LTD.; owlerton green; sheffield, , gb S6 2B J; UK S6 2BJ
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 18474147
• Report Number: 9611194-2024-00001
• Device Sequence Number: 6944078
• Product Code: GES
• UDI-Device Identifier: 05033955002053
• UDI-Public: 05033955002053
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NO.15 CARBON STERILE BLADE
• Device Catalogue Number: 0205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown